2019 Novel Coronavirus InfectionPhase 2NCT04778059

Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19

A Phase 2 study testing USB002 in people with 2019 Novel Coronavirus Infection and COVID-19 Virus Infection, run by US Biotest, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This trial will study the use of USB002 given as an intravenous infusion in patients with respiratory distress due to infection with COVID-19. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: 2019 Novel Coronavirus Infection, COVID-19 Virus Infection, SARS Coronavirus 2 Infection
What is being tested?: USB002
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 27 Jul 2021to 10 May 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent from patient or legal representative;
Age 18 or greater;
Positive reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 (≤10 days);
Respiratory rate > 20 RR;
SpO2 < 94% on room air, requiring supplemental oxygen, requiring invasive mechanical ventilation, or requiring ECMO;
Chest X-ray confirming bilateral pulmonary infiltrates;
Body mass index of ≤ 40 units/kg/m2;
Adequate method of birth control.

Who cannot join

Terminally ill patients due to underlying cardiac, cancer or severe debilitating neurological disease including coma;
Hospitalization expected to be < 96 hours due to medical improvement;
Interstitial lung disease;
Correction of QTc values obtained by 12 lead EKG using Fredericia's formula (QTcF) > 450 ms;
History of hypotension (mean arterial blood pressure < 65 mmHg), unrelated to CoVID-19 infection;
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times upper limit of normal;

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Participating concurrently on another clinical trial for the experimental treatment of COVID-19;
Active chemotherapy use;
Pregnant and/or lactating women.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals
Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: Phase 2 Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravenous USB002 to Treat Patients With Respiratory Distress Due to COVID-19 Infection

This trial will study the use of USB002 given as an intravenous infusion in patients with respiratory distress due to infection with COVID-19.

Conditions: 2019 Novel Coronavirus Infection, COVID-19 Virus Infection, SARS Coronavirus 2 Infection, SARS-CoV-2 Infection, Respiratory Distress Syndrome, Adult, Adult Respiratory Distress Syndrome
Being tested: USB002, Placebo
Medical subject headings: COVID-19, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

USB002Drug
USB002 is pharmaceutically formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (A-II), and is suspended in a vehicle as a sterile solution of USB002. Depending upon cohort assignment, subjects in the USB002 group will receive one of four doses of USB002 administered intravenously (IV).
PlaceboDrug
The placebo formulation will be the USB002 formulated solution without the addition of A(1-7). The placebo will be administered intravenously (IV).

Study groups in NCT04778059
Study group	Role	What they receive
USB002	Experimental	Not described Receives: Drug: USB002
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (TEAE)
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Measured: Day 1 to Day 70 (or date of final measurement, if sooner)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 202110 May 2022

First posted2 Mar 2021
Study start27 Jul 2021
Primary completion10 May 2022
Study completion10 May 2022

Why it stopped: Unable to enroll in timely manner due to nature of COVID

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 2019 Novel Coronavirus InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04778059
Sponsor's protocol ID: USB002-2020-001
Status last verified: Nov 2023
First submitted: 26 Feb 2021
Last updated: 1 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravenous USB002 to Treat Patients With Respiratory Distress Due to COVID-19 Infection
ClinicalTrials.gov ID: NCT04778059
Acronym / sponsor ID: USB002-2020-001
Conditions: 2019 Novel Coronavirus Infection, COVID-19 Virus Infection, SARS Coronavirus 2 Infection, SARS-CoV-2 Infection, Respiratory Distress Syndrome, Adult, Adult Respiratory Distress Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to enroll in timely manner due to nature of COVID
Enrolment: 21 participants (actual)
Lead sponsor: US Biotest, Inc.Industry (pharma, biotech, devices)
Study start: 27 Jul 2021 (actual)
Primary completion: 10 May 2022 (actual)
Study completion: 10 May 2022 (actual)
First posted: 2 Mar 2021 (actual)
Results: Posted 1 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial will study the use of USB002 given as an intravenous infusion in patients with respiratory distress due to infection with COVID-19.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
USB002	Experimental	Drug: USB002
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Signed informed consent from patient or legal representative;
Age 18 or greater;
Positive reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 (≤10 days);
Respiratory rate > 20 RR;
SpO2 < 94% on room air, requiring supplemental oxygen, requiring invasive mechanical ventilation, or requiring ECMO;

Key exclusion criteria (9 listed)

Terminally ill patients due to underlying cardiac, cancer or severe debilitating neurological disease including coma;
Hospitalization expected to be < 96 hours due to medical improvement;
Interstitial lung disease;
Correction of QTc values obtained by 12 lead EKG using Fredericia's formula (QTcF) > 450 ms;
History of hypotension (mean arterial blood pressure < 65 mmHg), unrelated to CoVID-19 infection;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
USB002USB002 is pharmaceutically formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (A-II), and is suspended in a vehicle as a sterile solution of USB002. Depending upon cohort assignment, subjects in the USB002 group will receive one of four doses of USB002 administered intravenously (IV).	Drug	USB002
PlaceboThe placebo formulation will be the USB002 formulated solution without the addition of A(1-7). The placebo will be administered intravenously (IV).	Drug	Placebo

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAE)
Time frame: Day 1 to Day 70 (or date of final measurement, if sooner)
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

Results and safety

Results posted to the registry on 1 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
USB002 90 ug/kg/Day	3	1
USB002 300 ug/kg/Day	3	1
USB002 600 ug/kg/Day	3	2
USB002 900 ug/kg/Day	2	1
Placebo	10	7

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAE)

Time frame: Day 1 to Day 70 (or date of final measurement, if sooner). Count of participants. Unit: Participants

Measure	USB002 90 ug/kg/Day n = 3	USB002 300 ug/kg/Day n = 3	USB002 600 ug/kg/Day n = 3	USB002 900 ug/kg/Day n = 2	Placebo n = 10
Value	2	3	2	2	8

Population analysed: All enrolled subjects who received a USB002 or Placebo infusion were included in the analysis population for all outcomes analyzed.

Adverse events

Time frame: Up to 70 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
USB002 90 ug/kg/Day	2 of 3 (66.7%)	2 of 3 (66.7%)	2 of 3
USB002 300 ug/kg/Day	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
USB002 600 ug/kg/Day	1 of 3 (33.3%)	2 of 3 (66.7%)	1 of 3
USB002 900 ug/kg/Day	1 of 2 (50%)	2 of 2 (100%)	1 of 2
Placebo	1 of 10 (10%)	8 of 10 (80%)	1 of 10

Limitations and caveats (from the sponsor): Per protocol, this clinical trial was designed to include two parts (Part 1 - dose escalation phase; Part 2 - dose expansion phase). Part 2 did not proceed due to enrolment difficulty. Sponsor encountered challenges in finding subjects that met study eligibility criteria. This was likely due to the role COVID-19 vaccinations played, limiting the spread and hospitalizations of COVID-19 patients. Sponsor terminated the trial early, when 21 subjects (all Part 1) had been enrolled.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sairam Parthasarathy, MD principal investigator

The University of Arizona Health Sciences Center/ Banner Healthcare Systems Hospitals

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing USB002 in people with 2019 Novel Coronavirus Infection and COVID-19 Virus Infection, run by US Biotest, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (TEAE) (time frame: Day 1 to Day 70 (or date of final measurement, if sooner)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04778059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.